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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00437970




Registration number
NCT00437970
Ethics application status
Date submitted
18/02/2007
Date registered
21/02/2007
Date last updated
27/05/2016

Titles & IDs
Public title
Medication in Early Diabetes (MED) Study
Scientific title
Drug naïve Indigenous Australians With Type 2 Diabetes, Enrolled in a Randomised Controlled Trial of Rosiglitazone Versus Metformin Monotherapy to Assess the Effects on Metabolic and Cardiovascular Parameters
Secondary ID [1] 0 0
DART-MSHR-06-29
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pioglitazone
Treatment: Drugs - Metformin

Active Comparator: A - Arm A- Metformin

Active Comparator: B - Arm B- Pioglitazone


Treatment: Drugs: Pioglitazone
15mg of Pioglitazone taken orally twice a day

Treatment: Drugs: Metformin
500 mg of Metformin taken orally twice a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c values
Timepoint [1] 0 0
second monthly
Primary outcome [2] 0 0
Weight gain
Timepoint [2] 0 0
monthly
Primary outcome [3] 0 0
Weight distribution
Timepoint [3] 0 0
six monthly
Primary outcome [4] 0 0
Medication side effects
Timepoint [4] 0 0
monthly
Secondary outcome [1] 0 0
Medication compliance
Timepoint [1] 0 0
monthly
Secondary outcome [2] 0 0
Side effects
Timepoint [2] 0 0
monthly
Secondary outcome [3] 0 0
Lipids
Timepoint [3] 0 0
second monthly
Secondary outcome [4] 0 0
Endothelial dysfunction.
Timepoint [4] 0 0
second monthly

Eligibility
Key inclusion criteria
- Drug naïve Indigenous Australians with Type 2 Diabetes

- Permanent resident of Darwin for at least 1 year immediately before and expected to be
for at least 1 year after study commences

- Participants must be able to give informed voluntary consent

- Both males and females (females of child bearing potential excluded if not on reliable
means of contraception)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2009
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Menzies School of Health Research - Darwin
Recruitment postcode(s) [1] 0 0
0810 - Darwin

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study compares metformin (current first-line medication) to pioglitazone (a newer
diabetic medication currently approved for combination use). Whilst there is good evidence
for the benefits of pioglitazone use in other populations, in light of the known weight gain
effects of pioglitazone we believe further assessment is required in Indigenous Australians
(in whom there is a strong predisposition for central fat deposition). This study will
provide evidence regarding the medication appropriate for first line medication in Type 2
diabetes in this high risk population. This study will assist clinicians to make
evidenced-based decisions regarding initial medical management of those with Type 2 diabetes
(where there is currently a gap in evidence).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00437970
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Louise Maple Brown, MBBS PhD FRACP
Address 0 0
Menzies School of Health Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00437970